Rationale and design of a Scale-Up Project Evaluating Responsiveness to Home Exercise And Lifestyle Tele-Health (SUPER-HEALTH) in people with physical/mobility disabilities: a type 1 hybrid design effectiveness trial

Introduction Rates of physical inactivity among people with physical disabilities are substantially higher than in the general population and access to home-based tailored exercise programmes is almost non-existent. Using a theory-driven eHealth platform, an innovative exercise programme referred to as movement-to-music (M2M) will be delivered as a customised, home-based exercise intervention for adults with mobility disabilities. Methods and analysis Participants are being recruited for this type 1 hybrid design based effectiveness trial through outpatient clinics at a large rehabilitation centre and randomised to one of three groups: (1) M2M, (2) M2M plus social networking (M2Mplus) and (3) attention control (AC). The intervention includes a 12-week adoption phase, 12-week transition phase and 24-week maintenance phase, at which the collection of objective measures on exercise, fitness and self-reported measures on health will be obtained at the start of each phase and at follow-up. The study compares the effectiveness of M2M and M2Mplus in increasing physical activity (primary outcome), adherence, fitness and physical functioning compared with the AC group and examines the mediators and moderators of the treatment effect. Ethics and dissemination The Institutional Review Board of The University of Alabama at Birmingham granted full approval: (IRB-160923002). Dissemination of findings will include publication in peer-reviewed journals, presentations at regional, national and/or international meetings, and the National Center on Health, Physical Activity and Disability (NCHPAD, www.nchpad.org). This study will strengthen our understanding of the potential benefits of eHealth exercise interventions for people with physical disabilities and build on strategies that aim to recruit larger samples in exercise trials. Trial registration number NCT03024320; Pre-results.

innovative exercise program referred to as movement-to-music (M2M) will be delivered as a customized, home-based exercise intervention for adults with mobility disabilities.

Methods and analysis:
Participants are being recruited for this randomized controlled trial through outpatient clinics at a large rehabilitation center and randomized to one of three groups: a) M2M; b) M2M plus social networking (M2M plus ); and c) attention control (AC). The intervention includes a 12-week adoption phase, 12-week transition phase, and 24-week maintenance phase, at which the collection of objective measures on exercise, fitness and self-reported measures on health will be obtained at the start of each phase and at follow-up. The study compares the effectiveness of M2M and M2M plus in increasing physical activity, adherence, fitness, and physical functioning compared to the AC group and examine the mediators and moderators of the treatment effect.

Ethics and dissemination: The Institutional Review Board of The University of Alabama at
Birmingham granted full approval: (IRB-160923002). Dissemination of findings will include publication in peer-reviewed journals, presentations at regional, national, and/or international meetings, and the National Center on Health, Physical Activity and Disability (NCHPAD, www.nchpad.org). This scalability study will strengthen our understanding of the potential benefits of eHealth exercise interventions for people with physical disabilities and build upon strategies that aim to recruit larger samples in exercise trials.

Strengths and limitations of this study
The trial is the largest of its kind exploring the use of telehealth technology to improve access to regular and sustainable home exercise among an underserved population of adults with mobility disabilities.  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   3 The trial addresses a growing need among physicians treating patients with mobility disabilities to have easily accessible e-Health home exercise videos that can be tailored to the functional level of their patients.
Utilizing constant monitoring technology will allow researchers to know when participants are not engaged in the intervention and prompt coaching calls to reduce dropout.
Recruitment will occur through a single rehabilitation hospital network and may not be generalizable to other regions across the United States and other countries.

BACKGROUND
Despite what is known about the positive effects of exercise in improving health and function, 1 people with physical disabilities remain one of the most least active and obese [2][3][4][5][6][7][8] populations in society. In the latest data from the Centers for Disease Control and Prevention, nearly one half of all adults with disabilities get no aerobic physical activity. 9 These patterns of low physical activity become more problematic across the lifespan when the effects of the natural aging process are compounded by years of sedentary living, poor nutrition and severe deconditioning. [10][11][12][13] In addition to the physical impairments associated with a disability limiting physical activity, initiating and maintaining a physically active lifestyle is difficult for people with physical disabilities due to a number of barriers faced in the home, built environment (neighborhood, community-based exercise and recreation facilities) and healthcare system. 14 Dozens of papers have reported that the built environment creates substantial limitations in accessing outdoor and indoor physical activity programs and venues. [15][16][17][18] Outdoor exercise may be challenging or impossible because many neighborhoods either lack sidewalks or have badly damaged surfaces presenting a high risk of falling among people who have poor balance and/or use wheelchairs. 19 Also, high traffic volume can be intimidating for many people with a mobility disability who have difficulty getting across streets in the time allotted by the traffic light. 20 In terms of getting to an indoor facility such as a fitness center, lack of accessible transportation is often the number one barrier to using these facilities followed by cost of the membership. 20 Recent data found that people with physical disabilities who were advised by their doctor to exercise were 82 percent more likely to do so. 9 However, the current healthcare system continues to provide little guidance to people with physical disabilities on how to exercise, leaving many, if not most, minimally prepared to manage or improve their health and fitness. 21 22 Therefore, healthcare providers require exercise programs that they can recommend to their  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  In recent years, Internet-based interventions targeting health issues such as nutrition, smoking, physical activity, or multiple health behaviors have become increasingly popular. 23 These interventions have several advantages for people with physical disabilities. In addition to the interactive and convenient nature of Internet-based programs, health professionals can utilize Web-platforms to provide tailored information to individual users and potentially reach large groups of people with physical disabilities at relatively low cost. A notable benefit of eHealth programs for people with physical disabilities includes the ability to participate at home, which is the most convenient place for many people with physical/mobility disabilities to engage in sustained physical activity behavior. If designed properly, home-based exercise allows for prompt feedback, individual tailoring, and continued personalized guidance and social support. 24 Thus, Internet-based exercise programs create an accessible venue for people with physical disabilities to achieve the exercise regimens prescribed by a health professional and can potentially include individuals who do not have access to conventional community-based exercise programs.
To fully address the barriers to accessing exercise, including the need for healthcare providers to have off-the-shelf resources that they can quickly provide to their patients, technology can play a substantial role in the delivery of home-based exercise to people with physical disabilities. Providing exercise opportunities in the comfort of a person's home would increase the opportunity for regular and sustainable exercise that is currently not available in most communities across the U.S. The proposed scale up exercise intervention will enroll a large cohort of adults with mobility disabilities from a university-based outpatient rehabilitation center to determine if an innovative home-based exercise program can achieve improvements in physical activity adherence, health and functional outcomes. The study is referred to as  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   7 brochures placed in clinics, society events, newsletters, advertisements, and word of mouth.
Additionally, recruitment will include screening more male participants than females.
In order to enhance the likelihood of enrollment through clinician referral, 27  Physical mail-outs are being delivered to potential participants that are identified from the NIH-funded National Center for Biomedical Computing based at Partners HealthCare System: Informatics for Integrating Biology and the Bedside (i2b2) [https://www.i2b2.org/about/index.html]. The i2b2 has been used to identify study cohorts within the outpatient rehabilitation clinics and address research questions by integrating a wide variety of clinical data sources. After an initial search query of participants located within the same state where the study is being conducted, and who attend one of the outpatient clinics, we identified approximately 5,400 people with neuromuscular disorders and musculoskeletal conditions. This list directs the physical mail-outs, which include a flyer that describes the study and a letter cosigned by the chair of department overseeing the clinics and the principal investigator. Mail-outs are being sent in batches of 100 every 2 to 4 weeks and will be increased or decreased depending on the response rate.

Exclusion criteria
Individuals with a mobility disability are eligible for the study. In order to remain consistent with other studies, 4 this was defined as self-reported difficulty (1) walking (some, much, unable to do) without special equipment use; (2) walking one-quarter of a mile; (3) remaining on feet for more than two hours; (4) taking 10 uninterrupted steps; (5) kneeling, stooping, or crouching; or (5) standing up from an armless straight chair. Individuals who meet the following criteria are not eligible to participate: accumulating more than 60 minutes of moderate/vigorous physical activity per week; do not report having a diagnosis of a physical/mobility disability; not within working age (18 to 64 yrs. of age); currently enrolled in a structured exercise program over the past 6 months; unable to use upper, lower or both sets of extremities to exercise; unable to converse and read English; medically unstable to perform home exercise as determined by their physician; cognitive impairment that may preclude self-directed daily activities no Internet access.

Study Procedures
The study flow diagram includes three phases of the intervention, Adoption (weeks 1 to 12), Transition (weeks 13 to 24), and Maintenance (weeks 25 to 48) ( Figure 1). This phased approach allows for gradual adjustment in the dosage of the intervention and the ability to capture changes within and across phases. Details of the interventions offered in each arm are shown in Table 1.
[Insert Figure 1] [Insert Table 1] All data storage is established via the Research Electronic Data Capture (REDCap), 28 an electronic data capture system. When potential participants fill in their information via the study website, it is automatically stored in REDCap. Potential participants' information with other methods of contact (e.g., mail-back, call) is manually entered into REDCap by the recruitment coordinator. The recruitment coordinator reaches out to potential participants within 48-72 hours based on their preferred contact methods (i.e., phone, emails) for more information regarding the study as well as participation eligibility. If eligible, the participant will be consented over the phone and will then receive baseline surveys to be completed online prior to testing visit. Once participants complete the baseline testing they will be randomized.
After the group allocation, participants receive a study designated email address which is uploaded to REDCap. Surveys are automatically sent at the remaining follow-up time points, 12 weeks, 24 weeks, and 48 weeks, to the new email address. There is a 10-day window open before and after the exact date of follow-up data collection based on the initial lab testing date.
Participants receive the same email a maximum of five times (1 per day) if they do not complete the survey. When a research staff member notices the missing data after 5 days, the participant is contacted by phone.
Fitness and physical function measures are assessed in a research lab within a stateof-the-art universally designed community health and fitness facility. Transportation is provided to the participants, if needed. After a review of the consent form, the lab staff completes anthropometric measures (height, weight, waist circumference) and vital signs (blood pressure, heart rate). Participant then complete a battery of fitness and physical function measures (see Table 2) while lab staff record results in a data collection packet.
The technology coordinator then familiarizes participants with the equipment and also guides participants through the tablet app. Equipment instructions cover basic operation (e.g., turning the devices on and off, connecting to Wi-Fi, etc.) and maintenance skills (e.g., cleaning the devices and damage prevention). Regarding app use, participants are carefully guided through the tablet app content and functions. Following these instructions, participants are then asked to independently navigate through the app and view all content.
The tablet app includes the foundational elements required for rapid deployment of the video and textual content, and is password protected to enable detailed usage tracking. The home page of the app provides brief weekly objectives and links to newly received content.
Other features of the app include a video and article library, calendar for scheduling, and activity dashboard with Fitbit data. In addition to these features, the M2M plus group's version of the app includes elements that support social interaction. These ancillary features include the ability to private-message other users, leaderboards that display user progress, a user profile, newsfeed, and the ability to comment on and "like" the exercise videos. The app version for the intervention groups (M2M and M2M plus ) includes exercise video content, while the AC group will only receive access to the infographics and the Fitbit dashboard.

Educational Resources
Each group receives textual content (i.e., articles, infographics) aimed at improving health through lifestyle changes and tailored to adults with mobility disabilities. This content includes physical activity recommendations, how to maintain activity, developing healthy nutrition habits, ways to reduce stress, and other health-related information. Each group receives this content weekly for 12 weeks (Adoption phase), bi-weekly for the following 12 weeks (Transition phase), and monthly for the last 24 weeks (Maintenance phase). Exercise videos include movements that were adapted from an onsite program that has been conducted at a state-of-the-art fitness facility for people with disabilities. The onsite program incorporated an extensive set of movement routines that were choreographed to the functional needs of people with a range of physical disabilities. For the present study, we modified the onsite program into a video-based package that could be performed independently in the home. The goal of the home-based program is to slowly and safely progress participants towards achieving and maintaining 150 minutes of moderate-intensity physical activity per week, which is based on the guidelines provided by the American College of Sports Medicine. 29 30 The exercise intervention is referred to as Movement-2-Music (M2M). The M2M intervention includes three broad sub-programs or levels that can be arranged by program staff to meet the functional needs of the participant: 1) able to use all four limbs; 2) able to use only the upper limbs (e.g., someone with lower extremity paralysis); and 3) able to use only one side of the body to exercise (e.g., individuals with stroke/hemiparesis). The determination of the level for each participant is based on their baseline physical function assessments. Each M2M session includes four sets of exercise routines: flexibility, muscle strength, cardiorespiratory fitness, and balance. The video ends with a cool down breathing routine. Participants are instructed to complete the assigned M2M exercise videos three times per week. The session duration and exercise intensity is gradually increased throughout the program.  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59 1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y 13

Theoretical Framework
The intervention is grounded in the Social Cognitive Theory, 33  teaching participants self-regulation strategies such as goal setting, journaling, and reinforcements using infographics (all groups).

Attention control group
In addition to the Fitbit, the AC group receives a tablet that only includes the educational materials. After the 48-week assessment is completed, participants receive access to the exercise videos.

Randomization
Eligible participants are randomized into one of three arms with 1:1:1 allocation ratio using a permuted block randomization approach where the block size is unknown to the intervention staff. The randomization sequence is generated a priori using a computergenerated random schedule in a permuted block (SAS version 9.4). The randomization schedule is then embedded into a randomization module in REDCap. 28 This system allows  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   14   researchers to manage the information with a higher level of security, remove physical envelop, and set individual level of blinding within the system.
Staff performing recruitment, outcome measurements, and data entry for the primary outcomes are blinded to group allocation. However, due to the nature of the intervention, it is not possible to blind the staff administering interventions or the participants. Participants are instructed not to inform the data collection staff of their intervention status when they return for follow-up measures.

Outcome measures
Lab-based research outcome measures are administered at baseline, 12 weeks, and 48 weeks by independent evaluators blind to treatment assignment. Survey measures are automatically delivered by the REDCap system at baseline, 12 weeks, 24 weeks, and 48 weeks.
The primary outcomes are change in rates of exercise participation and adherence to the study protocol from baseline to transition (24 weeks 1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   15 techniques. The purpose of the call is to gather information on non-adherence and aid the participant in creating an action plan for meeting the prescribed activity. Health and physical function measures include a battery of tests performed at baseline, 12 weeks, and 48 weeks (see Table 2).  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  the role of health/motivational coaches in the study. Finally, we will be able to bring more efficiency in terms of power and effect size since our primary statistical analysis is based on mixed modeling approach. The mixed modeling approach accounts for correlation between measurements from the same participant that improves that improves power for the same effect size or provides us the ability to detect a lower effect size for the same power and aforementioned assumptions. 42 Mixed modeling technique also utilizes all the data available (that is imputes any missing outcome data). Hence, despite attrition we will have a larger sample size while conducting longitudinal analyses, which would again bring more power/sample efficiency.

Analyses
All statistical analyses are conducted in an intent-to-treat manner, at the individual level.
Statistical significance is evaluated at 0.05 levels after adjusting for multiple testing corrections using Bonferroni correction. In general, missingness in outcomes is handled by mixed models for repeated measures data. Quality control (QC) includes descriptive and graphical approaches to summarize baseline characteristics of all key variables.
The primary aim includes two hypotheses stating that the M2M and M2M plus interventions will lead to greater increases in exercise from baseline to the transition phase when compared to the AC group. The outcome variable will be a time-varying measure (two  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y 17 time points: baseline and transition phase) of exercise. Using accelerometer (Fitbit) data, total activity of a participant per day will be estimated. The baseline exercise measure will be calculated as the average exercise per day scored across a 7-day period prior to starting the intervention (Adoption phase). Similarly, the average exercise per day for each of the intervention phases will be estimated. The main hypothesis addresses the change in activity between baseline and transition phases across intervention groups. Baseline covariate measures will be included if differences are identified across intervention arms, or if inclusion of these covariates improves the corrected Akaike Information Criterion (AIC). 43 44 In addition to any baseline covariates, fixed effects will include intervention arms (M2M, M2M plus ), AC, Time (baseline, transition) and an Arms X Time interaction. Contrast statements will be used to test the null hypotheses in conjunction with the fitted model coefficients. The estimates of the change in exercise for each arm and their 95% confidence interval will also be reported. Secondary data analyses will include testing for non-linearity in the differences between change scores in exercise across the intervention phases and testing whether there were greater increases in exercise in M2M and/or M2M plus compared to AC from baseline to end of adoption and baseline to transition.

Ethics and dissemination
The IRB will remain informed of any protocol changes or adverse events for the safety of participants. The recruitment and project coordinators will consent each participant to the study.
Once the participant signs the informed consent, they receive a unique research ID code and no personally identifiable information will be linked to data collected for this study. Quality assurance procedures are used to minimize missing data, possible errors, and to correct errors before final database lock. After completion of data entry, two additional research staff (project coordinator and data reviewer) audit data periodically and lock the record. When the survey is submitted to REDCap, research staff receive a notification via email and review the data within 48 hours. An independent Data Safety and Monitoring Committee is not necessary due to the  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y 18 minimal risk associated with participant outcomes. All data collection will be overseen by the principal investigator and co-investigators, including a biostatistician and physician.
Findings from this study will be shared publicly and disseminated by: (1) publication in peer-reviewed journals; and/or (2) presentations at regional, national, and/or international meetings. Findings will also be disseminated through the National Center on Health, Physical Activity and Disability (NCHPAD, www.nchpad.org), which has over 20,000 email subscribers. If the M2M exercise intervention achieves successful outcomes, we will make the program available to other medical centers through the NCHPAD website.
Data Sharing: We are committed to the sharing of final research data, being mindful that the rights and privacy of our research participants must be protected at all times, that there is the need to protect patentable and other proprietary data (ie, our web-based platform), and that restrictions on data sharing may be imposed by agreements with third parties. Published data with non-identifiers will also be shared with the 2018 Physical Activity Guidelines committee upon request.
Patient and Public Involvement: There was no patient or public involvement in the design of this study.
Competing Interests: No authors have any competing interests.

DISCUSSION
This paper has presented the background and design for a randomized controlled trail investigating the effectiveness of a home-based, eHealth exercise program for adults with mobility disabilities. To our knowledge, this study is the largest exercise trial ever conducted on people with mobility disabilities.
Engaging in the recommended levels of physical activity (150 minutes of moderate intensity physical activity per week) can be extremely challenging for many people with mobility disabilities, who have limited to no access to home exercise equipment, and indoor and outdoor physical activity programs and venues (e.g., outdoor parks, fitness facilities). 15-18 45 In  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  The low level of exercise participation observed in people with mobility disabilities likely have a negative impact on their health. Nearly one-half of people with disabilities are physically inactive, which the U.S. Centers for Disease Control and Prevention defines as not engaging in any aerobic physical activity, and this large inactive subgroup is 50 percent more likely to have a chronic disease compared to those who get the recommended amount of aerobic physical activity on a weekly basis. 9 Unfortunately, the current U.S. healthcare system is woefully underprepared to prescribe recommended exercise to people with mobility disabilities, leaving many, if not most, minimally prepared to manage or improve their own health and fitness as they grow older and have more health issues. 21 22 49 Health care providers clearly need more exercise resources that they can recommend to their patients with disabilities that are evidencebased, easily accessible, and tailored to their specific functional level.
The SUPER-HEALTH project addresses this growing epidemic of physical inactivity among people with mobility disabilities by providing simple access to an exercise program  Second, with transportation and program costs being two of the most common barriers reported among people with mobility disabilities in terms of obtaining regular exercise, 17 51-54 home-based programs with cloud-based technology and social support hold strong potential for reaching them in their home. Third, the telehealth technology used in this study is complemented by the latest innovation in activity monitoring. The Fitbit is a state-of-the-art accelerometer that provides an objective measure of physical activity during activity monitoring compared to selfreport measures. Fourth, the Internet-based home training package (aerobics, strength, flexibility and balance) is provided in the form of music, which offers greater levels of enjoyment and increases its potential for future scalability. The exercise routines can be mixed and matched with new music and movement patterns, which keeps the exercise routines novel.
Finally, the use of an eHealth platform has the potential to shift relatively large segments of the population of people with mobility disabilities from inactive to physically active in a sustainable way that extends beyond the intervention timeframe.

CONCLUSION
SUPER-HEALTH is a multi-level scale up exercise eHealth intervention using healthcare providers as the point-of-entry for enrolling patients with mobility disabilities into the study. If SUPER-HEALTH proves efficacious, promotion of health-enhancing exercise for people with mobility disabilities through an eHealth movement-to-music (M2M) intervention (targeted to  Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) __20____

Methods: Assignment of interventions (for controlled trials)
Allocation: Sequence generation 16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions ____12_______ Allocation concealment mechanism 16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned _____11-12_____ Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will assign participants to interventions ____8_______ Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome assessors, data analysts), and how ____12_______ 17b If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant's allocated intervention during the trial _____n/a_____

Data collection methods 18a
Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol __13-14 ; table 2__ 18b Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols _____13________ Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any statistical methods to handle missing data (eg, multiple imputation) _____15-16_____

Methods: Monitoring
Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and competing interests; and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed _____16_____ 21b Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial ___n/a_____  innovative exercise program referred to as movement-to-music (M2M) will be delivered as a 20 customized, home-based exercise intervention for adults with mobility disabilities.  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  The study compares the effectiveness of M2M and M2M plus in increasing physical activity, 2 adherence, fitness, and physical functioning compared to the AC group and examine the 3 mediators and moderators of the treatment effect. 4

Ethics and dissemination:
The Institutional Review Board of The University of Alabama at 5 Birmingham granted full approval: (IRB-160923002). Dissemination of findings will include 6 publication in peer-reviewed journals, presentations at regional, national, and/or international 7 meetings, and the National Center on Health, Physical Activity and Disability (NCHPAD ,  8 www.nchpad.org). This study will strengthen our understanding of the potential benefits of 9 eHealth exercise interventions for people with physical disabilities and build upon strategies that 10 aim to recruit larger samples in exercise trials. 11 Trial registration number: NCT03024320 12 13

Strengths and limitations of this study 14
The trial is the largest of its kind exploring the use of telehealth technology to improve 15 access to regular and sustainable home exercise among an underserved population of 16 adults with mobility disabilities. 17 The trial addresses a growing need among physicians treating patients with mobility 18 disabilities to have easily accessible e-Health home exercise videos that can be tailored to 19 the functional level of their patients. 20 Utilizing constant monitoring technology will allow researchers to know when participants are 21 not engaged in the intervention and prompt coaching calls to reduce dropout.  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  Despite what is known about the positive effects of exercise in improving health and 2 function, 1 people with physical disabilities remain one of the least active and obese 2-8 3 populations in society. In the latest data from the Centers for Disease Control and Prevention, 4 nearly one half of all adults with disabilities get no aerobic physical activity. 9 These patterns of 5 low physical activity become more problematic across the lifespan when the effects of the 6 natural aging process are compounded by years of sedentary living, poor nutrition and severe 7 deconditioning. 10-13 8 In addition to the physical impairments associated with a disability limiting physical 9 activity, initiating and maintaining a physically active lifestyle is difficult for people with physical 10 disabilities due to a number of barriers faced in the home, built environment (neighborhood, 11 community-based exercise and recreation facilities) and healthcare system. 14 Dozens of papers 12 have reported that the built environment creates substantial limitations in accessing outdoor and 13 indoor physical activity programs and venues. [15][16][17][18] Outdoor exercise may be challenging or 14 impossible because many neighborhoods either lack sidewalks or have badly damaged 15 surfaces presenting a high risk of falling among people who have poor balance and/or use 16 wheelchairs. 19 Also, high traffic volume can be intimidating for many people with a mobility 17 disability who have difficulty getting across streets in the time allotted by the traffic light. 20 In 18 terms of getting to an indoor facility such as a fitness center, lack of accessible transportation is 19 often the number one barrier to using these facilities followed by cost of the membership. 20 20 Recent data found that people with physical disabilities who were advised by their doctor 21 to exercise were 82 percent more likely to do so. 9 However, the current healthcare system 22 continues to provide little guidance to people with physical disabilities on how to exercise, 23 leaving many, if not most, minimally prepared to manage or improve their health and fitness. 21 22 24 Therefore, healthcare providers require exercise programs that they can recommend to their 25 In recent years, Internet-based interventions targeting health issues such as nutrition, 3 smoking, physical activity, or multiple health behaviors have become increasingly popular. 23 4 These interventions have several advantages for people with physical disabilities. In addition to 5 the interactive and convenient nature of Internet-based programs, health professionals can 6 utilize Web-platforms to provide tailored information to individual users and potentially reach 7 large groups of people with physical disabilities at relatively low cost. A notable benefit of 8 eHealth programs for people with physical disabilities includes the ability to participate at home, 9 which is the most convenient place for many people with physical/mobility disabilities to engage 10 in sustained physical activity behavior. If designed properly, home-based exercise allows for 11 prompt feedback, individual tailoring, and continued personalized guidance and social support. 24 12 Thus, Internet-based exercise programs create an accessible venue for people with physical 13 disabilities to achieve the exercise regimens prescribed by a health professional and can 14 potentially include individuals who do not have access to conventional community-based 15 exercise programs. 16 To fully address the barriers to accessing exercise, including the need for healthcare 17 providers to have off-the-shelf resources that they can quickly provide to their patients, 18 technology can play a substantial role in the delivery of home-based exercise to people with 19 physical disabilities. Providing exercise opportunities in the comfort of a person's home would 20 increase the opportunity for regular and sustainable exercise that is currently not available in 21 most communities across the U.S. The proposed scale up exercise intervention will enroll a 22 large cohort of adults with mobility disabilities from a university-based outpatient rehabilitation 23 center to determine if an innovative home-based exercise program can achieve improvements 24 in physical activity adherence, health and functional outcomes. The study is referred to as 25 This study aims to test the effectiveness of a home-based e-Health exercise program for 3 increasing physical activity among a clinical population of people with mobility disabilities. The 4 intervention, referred to as Movement-to-Music (M2M), is being compared to an enhanced 5 version of M2M that includes social networking (M2M plus ). Both of these interventions are 6 compared to an attention control (AC) group. Secondary aims include (1) estimating 7 improvements in health (pain, sleep, quality of life) and physical function (balance, strength, 8 endurance) between M2M and M2M plus groups compared to the AC group; and (2) assessing 9 mediators and moderators of social cognitive theory (self-efficacy, self-regulation, social 10 support, outcome expectancies) and demographic factors (age, race, disability type) of the 11 hypothesized treatment effect to understand for whom and how the intervention is effective. 12

METHODS 13
This protocol was approved by the University's Institutional Review Board (IRB-14 160923002) and is registered with ClinicialTrials.gov (#NCT03024320) as a phase III clinical 15 trial. This paper follows the SPIRIT checklist 25 , TIDieR checklist 26 , and conduct and reporting of 16 the trial follows CONSORT guidelines. 27 17

Study design 18
SUPER-HEALTH is a single site, three-arm parallel group type 1 hybrid design based 19 effectiveness trial 28 29 evaluating the effects of two intervention groups (M2M and M2M plus ) 20 compared to AC in people with mobility disabilities, with assessments conducted at four time 21 points: baseline, 12 weeks, 24 weeks, and 48 weeks.  Additionally, recruitment will include screening more male participants than females. 2 In order to enhance the likelihood of enrollment through clinician referral, 30   where the study is being conducted, and who attend one of the outpatient clinics, we identified 20 approximately 5,400 people with neuromuscular disorders and musculoskeletal conditions. This 21 list directs the physical mail-outs, which include a flyer that describes the study and a letter co-22 signed by the chair of department overseeing the clinics and the principal investigator. Mail-outs 23 are being sent in batches of 100 every 2 to 4 weeks and will be increased or decreased 24 depending on the response rate. 25 26 Individuals with a mobility disability are eligible for the study. In order to remain 2 consistent with other studies, 4 this was defined as self-reported difficulty (1) walking (some, 3 much, unable to do) without special equipment use; (2) walking one-quarter of a mile; (3) 4 remaining on feet for more than two hours; (4) taking 10 uninterrupted steps; (5) kneeling, 5 stooping, or crouching; or (5) standing up from an armless straight chair. Individuals who meet 6 the following criteria are not eligible to participate: 7 accumulating more than 60 minutes of moderate/vigorous physical activity per week; 8 do not report having a diagnosis of a physical/mobility disability; 9 not within working age (18 to 64 yrs. of age); 10 currently enrolled in a structured exercise program over the past 6 months; 11 unable to use upper, lower or both sets of extremities to exercise; 12 unable to converse and read English; 13 medically unstable to perform home exercise as determined by their physician; 14 cognitive impairment that may preclude self-directed daily activities 15 no Internet access. 16

Study Procedures 17
The study flow diagram includes three phases of the intervention, Adoption (weeks 1 to  Table 1 coordinator. The recruitment coordinator reaches out to potential participants within 48-72 hours 5 based on their preferred contact methods (i.e., phone, emails) for more information regarding 6 the study as well as participation eligibility. If eligible, the participant will be consented over the 7 phone and will then receive baseline surveys to be completed online prior to testing visit. Once 8 participants complete the baseline testing they will be randomized. 9 After the group allocation, participants receive a study designated email address which 10 is uploaded to REDCap. Surveys are automatically sent at the remaining follow-up time points, 11 12 weeks, 24 weeks, and 48 weeks, to the new email address. There is a 10-day window open 12 before and after the exact date of follow-up data collection based on the initial lab testing date. anthropometric measures (height, weight, waist circumference) and vital signs (blood pressure, 20 heart rate). Participant then complete a battery of fitness and physical function measures (see 21 Table 2) while lab staff record results in a data collection packet. 22

Interventions 23
After the lab assessments are completed, the technology coordinator provides the 24 participant with the appropriate equipment based on their group assignment and functional 25 level. The equipment includes a tablet (ASUS Zenpad 3s 10), a tablet case (Fintie Folio Stand 26 The technology coordinator then familiarizes participants with the equipment and also guides 3 participants through the tablet app. Equipment instructions cover basic operation (e.g., turning 4 the devices on and off, connecting to Wi-Fi, etc.) and maintenance skills (e.g., cleaning the 5 devices and damage prevention). Regarding app use, participants are carefully guided through 6 the tablet app content and functions. Following these instructions, participants are then asked to 7 independently navigate through the app and view all content. 8 The tablet app includes the foundational elements required for rapid deployment of the 9 video and textual content, and is password protected to enable detailed usage tracking. The 10 home page of the app provides brief weekly objectives and links to newly received content. 11 Other features of the app include a video and article library, calendar for scheduling, and activity 12 dashboard with Fitbit data. In addition to these features, the M2M plus group's version of the app 13 includes elements that support social interaction. These ancillary features include the ability to 14 private-message other users, leaderboards that display user progress, a user profile, newsfeed, 15 and the ability to comment on and "like" the exercise videos. The app version for the 16 intervention groups (M2M and M2M plus ) includes exercise video content, while the AC group will 17 only receive access to the infographics and the Fitbit dashboard. 18

Educational Resources 19
Each group receives textual content (i.e., articles, infographics) aimed at improving 20 health through lifestyle changes and tailored to adults with mobility disabilities. This content 21 includes physical activity recommendations, how to maintain activity, developing healthy 22 nutrition habits, ways to reduce stress, and other health-related information. Each group 23 receives this content weekly for 12 weeks (Adoption phase), bi-weekly for the following 12 24 weeks (Transition phase), and monthly for the last 24 weeks (Maintenance phase). 25 26 Exercise videos include movements that were adapted from an onsite program that has 2 been conducted at a state-of-the-art fitness facility for people with disabilities. The onsite 3 program incorporated an extensive set of movement routines that were choreographed to the 4 functional needs of people with a range of physical disabilities. For the present study, we 5 modified the onsite program into a video-based package that could be performed independently 6 in the home. Program modifications were made using a framework referred to as MAPPETT 7 The exercise intervention is referred to as M2M. The M2M intervention includes three 19 broad sub-programs or levels that can be arranged by program staff to meet the functional 20 needs of the participant: 1) able to use all four limbs; 2) able to use only the upper limbs (e.g., 21 someone with lower extremity paralysis); and 3) able to use only one side of the body to  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58 (7) conversations. 34  Additionally, M2M plus participants join a weekly video conference group discussion session led 1 by the project coordinator who has expertise in motivational interviewing strategies. The 2 purposes of these sessions are to stimulate discussion among participants and to encourage 3 them to support each other. Each session incorporates behavioral change strategies that have 4 been modified from previous research with adults with physical disabilities. 35 The sessions focus 5 on topics related to constructs from the Social Cognitive Theory (the theoretical background for 6 this study): social support, overcoming barriers, and preventing relapse.  In addition to the Fitbit, the AC group receives a tablet that only includes the educational 2 materials. After the 48-week assessment is completed, participants receive access to the 3 exercise videos. 4

Randomization 5
Eligible participants are randomized into one of three arms with 1:1:1 allocation ratio 6 using a permuted block randomization approach where the block size is unknown to the 7 intervention staff. The randomization sequence is generated a priori using a computer-8 generated random schedule in a permuted block (SAS version 9.4). The randomization 9 schedule is then embedded into a randomization module in REDCap. 31 This system allows 10 researchers to manage the information with a higher level of security, remove physical envelop, 11 and set individual level of blinding within the system. 12 Staff performing recruitment, outcome measurements, and data entry for the primary 13 outcomes are blinded to group allocation. However, due to the nature of the intervention, it is 14 not possible to blind the staff administering interventions or the participants. Participants are 15 instructed not to inform the data collection staff of their intervention status when they return for 16 follow-up measures. 17

Intervention Fidelity 18
The intervention uses the latest eHealth technology as a means to deliver and monitor 19 the intervention. Each participant receives the latest in activity monitoring (Fitbit), streaming, 20 content (M2M and M2M plus only), and a social networking platform (M2M plus only), which paired 21 with the use of cloud-based technology allows for the intervention to be administered in the 22 home. Our intervention fidelity plan (

Outcome measures 4
Lab-based research outcome measures are administered at baseline, 12 weeks, and 48 5 weeks by independent evaluators blind to treatment assignment. Survey measures are 6 automatically delivered by the REDCap system at baseline, 12 weeks, 24 weeks, and 48 weeks. 7 The primary outcome is change in rates of exercise participation. Exercise data is 8 collected with a self-report measure, the Godin Leisure-Time Exercise Questionnaire 9 (GLTEQ), 42 at the four time points. A secondary outcome is adherence to the study protocol 10 from baseline to transition (24 weeks), with an additional follow-up at 48 weeks. Adherence is 11 defined as the percentage the participant meets or exceeds the study protocol's weekly exercise 12 session attendance, which is measured by how many times the participant uses the app. The  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y Other outcomes include health and physical function measures, which involve a battery 1 of tests performed at baseline, 12 weeks, and 48 weeks (see Table 3). In addition, scales on exercise goal-setting, barriers to physical activity, outcome expectations for exercise, 8 social support, and exercise self-efficacy. Other measures include app usability, eHealth literacy 9 assessment, and demographics (i.e., race, sex, age). A brief tabulation of the measures for this 10 study including information on key outcome variables, covariates, and time points is shown in 11 Table 3. 12 [Insert Table 3]   1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60 F o r p e e r r e v i e w o n l y minimum detectable effect size of 0.375 is much smaller than the aforementioned effect sizes to 1 account for the variability in the effect sizes and winner's curse 47 (anticipated scenario given that 2 we aim to recruit a far larger sample size). An assumed attrition rate (AR) of 36% was based on 3 the study by Froehlich-Grobe et al. 46 While our prior studies had an AR as low as 13%, the 4 eHealth literature cautions of higher attrition rates. Achieving lower ARs may possibly relate to 5 the role of health/motivational coaches in the study. Finally, we will be able to bring more 6 efficiency in terms of power and effect size since our primary statistical analysis is based on 7 mixed modeling approach. The mixed modeling approach accounts for correlation between 8 measurements from the same participant that improves power for the same effect size or 9 provides us the ability to detect a lower effect size for the same power and aforementioned 10 assumptions. 47 Mixed modeling technique also utilizes all the data available (that is imputes any 11 missing outcome data). Hence, despite attrition we will have a larger sample size while 12 conducting longitudinal analyses, which would again bring more power/sample efficiency. 13

Analyses 14
All statistical analyses are conducted in an intent-to-treat manner, at the individual level. 15 For the single primary outcome statistical significance will be evaluated at a 2-tailed hypothesis-16 wise error rate of 0.05. Consistent with published guidelines for statistical reporting, exact p-17 values (rather than, e.g., "p < 0.05" or "NS") will be reported. 48 This allows readers who may 18 have their own opinions about multiple comparison corrections to know the raw uncorrected 19 result and make their own judgments about statistical significance especially given that the 20 significance tests conducted for primary outcome are specified a priori and modest in number. 21 As Saville 49 50 noted, in multiple comparison issues, there is no right answer and each 22 investigator must ultimately "cut the Gordian knot" themselves. For the secondary outcomes 23 statistical significance is evaluated at a family-wise error rate of 0.05 after accounting for 24 multiple outcomes testing. Based on the p-values for all analyses reported, we will also report 25 the false discovery rate and false discovery proportion. 26  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  For the primary outcome of physical activity, we will compare two planned pairwise 4 comparisons. The primary aim includes two hypotheses stating that the M2M and M2M plus 5 interventions will lead to greater increases in exercise from baseline to the transition phase 6 when compared to the AC group. The outcome variable will be a time-varying measure (two 7 time points: baseline and transition phase) of exercise. Using self-report data from the GLTEQ, 8 a Health Contribution Score will be calculated. 42 The baseline exercise measure will be 9 calculated as the average exercise week across a 7-day period prior to starting the intervention 10 (Adoption phase). Similarly, the average exercise for a 7-day period at the end of each 11 intervention phase will be estimated. The main hypothesis addresses the change in activity 12 between baseline and transition phases across intervention groups. Baseline covariate 13 measures will be included if differences are identified across intervention arms, or if inclusion of 14 these covariates improves the corrected Akaike Information Criterion (AIC). 51 52 15 In addition to any baseline covariates, fixed effects will include intervention arms (M2M, 16 M2M plus ), AC, Time (baseline, transition) and an Arms X Time interaction. Contrast statements 17 will be used to test the null hypotheses in conjunction with the fitted model coefficients. The 18 estimates of the change in exercise for each arm and their 95% confidence interval will also be 19 reported. Secondary data analyses will include testing for non-linearity in the differences 20 between change scores in exercise across the intervention phases and testing whether there 21 were greater increases in exercise in M2M and/or M2M plus compared to AC from baseline to end 22 of adoption and baseline to transition. 23

Ethics and dissemination 24
The IRB will remain informed of any protocol changes or adverse events for the safety of 25 participants. The recruitment and project coordinators will consent each participant to the study.  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y Once the participant signs the informed consent, they receive a unique research ID code and no 1 personally identifiable information will be linked to data collected for this study. Quality 2 assurance procedures are used to minimize missing data, possible errors, and to correct errors 3 before final database lock. After completion of data entry, two additional research staff (project 4 coordinator and data reviewer) audit data periodically and lock the record. When the survey is 5 submitted to REDCap, research staff receive a notification via email and review the data within 6 48 hours. An independent Data Safety and Monitoring Committee is not necessary due to the 7 minimal risk associated with participant outcomes. All data collection will be overseen by the 8 principal investigator and co-investigators, including a biostatistician and physician. 9 Findings from this study will be shared publicly and disseminated by: (1) publication in 10 peer-reviewed journals; and/or (2) presentations at regional, national, and/or international 11 meetings. Findings will also be disseminated through the National Center on Health, Physical 12 Activity and Disability (NCHPAD, www.nchpad.org), which has over 20,000 email subscribers. If 13 the M2M exercise intervention achieves successful outcomes, we will make the program 14 available to other medical centers through the NCHPAD website. We are committed to the 15 sharing of final research data, being mindful that the rights and privacy of our research 16 participants must be protected at all times, that there is the need to protect patentable and other 17 proprietary data (ie, our web-based platform), and that restrictions on data sharing may be 18 imposed by agreements with third parties. Published data with non-identifiers will also be shared 19 with the 2018 Physical Activity Guidelines committee upon request. 20

Study Design
Ensure intervention consistency with SCT. Protocol for eHealth platform maintenance and resolution of technical problems during study. Weekly delivery and notification of M2M videos to motivate participants to use. Phone coaching would assess the use of the eHealth platform and motivate intervention participants to complete their sessions. Password protection to ensure that participants access only material belonging to their study arm.
Wearing of Fitbit will be monitored and if no data showing for 7 days, the participant will be contacted by phone and/or email. Intervention delivered via eHealth platform, not via clinicians.

Provider Training
Training of all individuals who will be conducting the screening, phone coaching, and interviews. Manual of Operating procedure to contain standardized scripts for all interactions. Booster training sessions conducted every six months. Intervention will be delivered through eHealth platform in exactly the same way to all participants of the two intervention arms.

Delivery of Intervention
Prescribed behaviors (aerobic/strength moves), as defined by the M2M protocol, performed by the interventionist in M2M videos will be qualitatively and quantitatively assessed. Technology acceptance will be measured through perceived usefulness and ease of use scale that will provide information about the usability and the extent to which the participant has positive perceptions and intentions to use the platform. The research coordinator will regularly monitor the eHealth platform throughout the study to ensure videos and other materials were working correctly. Technical difficulties with the delivery of the intervention will be resolved in timely manner. The number of participants logins, clicks to video links and minutes watched will be monitored by tools on the intervention eHealth platform server.

Receipt of Intervention
Every time a participant views a M2M video, a timestamp and minutes viewed are recorded. Each time the participant reads an articles or opens a video, they have a check in button they press. 2   content on data management protocol. DP provided content for theoretical framework section. 7 All authors reviewed paper in full and provided revisions on the entire paper. 8

Study sponsorship, funding and organization 9
This work is supported by a grant from the National Institutes of Health, Eunice Kennedy 10 Shriver National Institute of Child Health and Human Development (1R01HD085186). This 11 study is sponsored by the University of Alabama at Birmingham and will be coordinated by the 12 Lakeshore Foundation, Birmingham, Alabama. The study funder will have no role in the conduct 13 or evaluation of the trial, nor the authority over the study design, analysis, interpretation of 14 results, or preparation of manuscripts or abstracts. 15

Data Sharing, Patient and Public Involvement, and Competing Interests 16
We are committed to the sharing of final research data, being mindful that the rights and 17 privacy of our research participants must be protected at all times, that there is the need to 18 protect patentable and other proprietary data (ie, our web-based platform), and that restrictions 19 on data sharing may be imposed by agreements with third parties. Published data with non-20 identifiers will also be shared with the 2018 Physical Activity Guidelines committee upon 21 request. There was no patient or public involvement in the design of this study.  Other † (details)

BRIEF NAME 1.
Provide the name or a phrase that describes the intervention. __Title Page_ ______________

2.
Describe any rationale, theory, or goal of the elements essential to the intervention. __1-5_______ _____________

3.
Materials: Describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers.
Provide information on where the materials can be accessed (e.g. online appendix, URL).

4.
Procedures: Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities.

5.
For each category of intervention provider (e.g. psychologist, nursing assistant), describe their expertise, background and any specific training given.

6.
Describe the modes of delivery (e.g. face-to-face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group.

11.
Planned: If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them.

ǂ
Actual: If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned.
____N/A______ _____________ ** Authors -use N/A if an item is not applicable for the intervention being described. Reviewers -use '?' if information about the element is not reported/not sufficiently reported. † If the information is not provided in the primary paper, give details of where this information is available. This may include locations such as a published protocol or other published papers (provide citation details) or a website (provide the URL). ǂ If completing the TIDieR checklist for a protocol, these items are not relevant to the protocol and cannot be described until the study is complete.  Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) __20____  content on data management protocol. DP provided content for theoretical framework section. 16 All authors reviewed paper in full and provided revisions on the entire paper.  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   2   1 innovative exercise program referred to as movement-to-music (M2M) will be delivered as a 2 customized, home-based exercise intervention for adults with mobility disabilities. week maintenance phase, at which the collection of objective measures on exercise, fitness and 8 self-reported measures on health will be obtained at the start of each phase and at follow-up.

19
terms of getting to an indoor facility such as a fitness center, lack of accessible transportation is 20 often the number one barrier to using these facilities followed by cost of the membership. 20

21
Recent data found that people with physical disabilities who were advised by their doctor

22
to exercise were 82 percent more likely to do so. 9 However, the current healthcare system 23 continues to provide little guidance to people with physical disabilities on how to exercise, 24 leaving many, if not most, minimally prepared to manage or improve their health and fitness. 21 22 25 Therefore, healthcare providers require exercise programs that they can recommend to their  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   5   1 patients with disabilities that are evidence-based, easily accessible, and tailored to the specific 2 functional and health-related needs of the individual.

3
In recent years, Internet-based interventions targeting health issues such as nutrition, 4 smoking, physical activity, or multiple health behaviors have become increasingly popular. 23 5 These interventions have several advantages for people with physical disabilities. In addition to 6 the interactive and convenient nature of Internet-based programs, health professionals can 7 utilize Web-platforms to provide tailored information to individual users and potentially reach 8 large groups of people with physical disabilities at relatively low cost. A notable benefit of 9 eHealth programs for people with physical disabilities includes the ability to participate at home,

10
which is the most convenient place for many people with physical/mobility disabilities to engage 11 in sustained physical activity behavior. If designed properly, home-based exercise allows for 12 prompt feedback, individual tailoring, and continued personalized guidance and social support. 24 13 Thus, Internet-based exercise programs create an accessible venue for people with physical

17
To fully address the barriers to accessing exercise, including the need for healthcare 18 providers to have off-the-shelf resources that they can quickly provide to their patients,

5
Additionally, recruitment will include screening more male participants than females.

6
In order to enhance the likelihood of enrollment through clinician referral, 32 research staff  where the study is being conducted, and who attend one of the outpatient clinics, we identified 24 approximately 5,400 people with neuromuscular disorders and musculoskeletal conditions. This 25 list directs the physical mail-outs, which include a flyer that describes the study and a letter co-26 signed by the chair of department overseeing the clinics and the principal investigator. Mail-outs  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   8   1 are being sent in batches of 100 every 2 to 4 weeks and will be increased or decreased 2 depending on the response rate. 3

Exclusion criteria
4 Individuals with a mobility disability are eligible for the study. In order to remain 5 consistent with other studies, 4 this was defined as self-reported difficulty (1) walking (some, 10  accumulating more than 60 minutes of moderate/vigorous physical activity per week;

11
 do not report having a diagnosis of a physical/mobility disability;

12
 not within working age (18 to 64 yrs. of age);

13
 currently enrolled in a structured exercise program over the past 6 months;

14
 unable to use upper, lower or both sets of extremities to exercise;

15
 unable to converse and read English;

16
 medically unstable to perform home exercise as determined by their physician; 17  cognitive impairment that may preclude self-directed daily activities 18  no Wi-FI Internet access. 19

20
The study flow diagram includes three phases of the intervention, Adoption (weeks 1 to  Table 1.

11
After the group allocation, participants receive a study designated email address which  exercise intensity is gradually increased throughout the program.

4
The exercise videos are delivered across the three intervention phases: 1) Adoption,     Eligible participants are randomized into one of three arms with 1:1:1 allocation ratio 6 using a permuted block randomization approach where the block size is unknown to the 7 intervention staff. The randomization sequence is generated a priori using a computer-8 generated random schedule in a permuted block (SAS version 9.4). The randomization 9 schedule is then embedded into a randomization module in REDCap. 33 This system allows 10 researchers to manage the information with a higher level of security, remove physical envelop,

11
and set individual level of blinding within the system.

12
Staff performing recruitment, outcome measurements, and data entry for the primary  automatically delivered by the REDCap system at baseline, 12 weeks, 24 weeks, and 48 weeks.

6
The primary outcome is change in rates of exercise participation, measured via self-7 report by the Godin Leisure-Time Exercise Questionnaire (GLTEQ), 44 at the four time points.
8 Secondary effectiveness outcomes include health and physical function measures, which 9 involve a battery of tests performed at baseline, 12 weeks, and 48 weeks (see Table 3). In  Table 3.

9
As Saville 51 52 noted, in multiple comparison issues, there is no right answer and each 10 investigator must ultimately "cut the Gordian knot" themselves. For the secondary outcomes 11 statistical significance is evaluated at a family-wise error rate of 0.05 after accounting for 12 multiple outcomes testing. Based on the p-values for all analyses reported, we will also report 13 the false discovery rate and false discovery proportion.
14 In general, missingness in outcomes is handled by mixed models for repeated measures 15 data. Quality control (QC) includes descriptive and graphical approaches to summarize baseline 16 characteristics of all key variables.

Ethics and dissemination
12 The IRB will remain informed of any protocol changes or adverse events for the safety of 13 participants. The recruitment and project coordinators will consent each participant to the study.
14 Once the participant signs the informed consent, they receive a unique research ID code and no 15 personally identifiable information will be linked to data collected for this study. Quality 16 assurance procedures are used to minimize missing data, possible errors, and to correct errors 17 before final database lock. After completion of data entry, two additional research staff (project 18 coordinator and data reviewer) audit data periodically and lock the record. When the survey is 19 submitted to REDCap, research staff receive a notification via email and review the data within 20 48 hours. An independent Data Safety and Monitoring Committee is not necessary due to the 21 minimal risk associated with participant outcomes. All data collection will be overseen by the 22 principal investigator and co-investigators, including a biostatistician and physician.

23
Findings from this study will be shared publicly and disseminated by: (1) publication in 24 peer-reviewed journals; and/or (2) presentations at regional, national, and/or international 25 meetings. Findings will also be disseminated through the National Center on Health, Physical

26
Activity and Disability (NCHPAD, www.nchpad.org), which has over 20,000 email subscribers. If  1  2  3  4  5  6  7  8  9  10  11  12  13  14  15  16  17  18  19  20  21  22  23  24  25  26  27  28  29  30  31  32  33  34  35  36  37  38  39  40  41  42  43  44  45  46  47  48  49  50  51  52  53  54  55  56  57  58  59  60   F  o  r  p  e  e  r  r  e  v  i  e  w  o  n  l  y   20   1 the M2M exercise intervention achieves successful outcomes, we will make the program 2 available to other medical centers through the NCHPAD website. We are committed to the 3 sharing of final research data, being mindful that the rights and privacy of our research 4 participants must be protected at all times, that there is the need to protect patentable and other 5 proprietary data (ie, our web-based platform), and that restrictions on data sharing may be 6 imposed by agreements with third parties. Published data with non-identifiers will also be shared 7 with the 2018 Physical Activity Guidelines committee upon request. 8

9
There was no patient or public involvement in the design of this study.

Study Design
Intervention delivered via eHealth platform, not via clinicians.
Training of all individuals who will be conducting the screening, phone coaching, and interviews. Manual of Operating procedure to contain standardized scripts for all interactions. Booster training sessions conducted every six months.

Provider Training
Intervention will be delivered through eHealth platform in exactly the same way to all participants of the two intervention arms. Prescribed behaviors (aerobic/strength moves), as defined by the M2M protocol, performed by the interventionist in M2M videos will be qualitatively and quantitatively assessed. Technology acceptance will be measured through perceived usefulness and ease of use scale that will provide information about the usability and the extent to which the participant has positive perceptions and intentions to use the platform. The research coordinator will regularly monitor the eHealth platform throughout the study to ensure videos and other materials were working correctly. Technical difficulties with the delivery of the intervention will be resolved in timely manner.

Delivery of Intervention
The number of participants logins, clicks to video links and minutes watched will be monitored by tools on the intervention eHealth platform server. Every time a participant views a M2M video, a timestamp and minutes viewed are recorded.
Provide the name or a phrase that describes the intervention. __Title Page_ ______________

2.
Describe any rationale, theory, or goal of the elements essential to the intervention. __1-5_______ _____________

3.
Materials: Describe any physical or informational materials used in the intervention, including those provided to participants or used in intervention delivery or in training of intervention providers.
Provide information on where the materials can be accessed (e.g. online appendix, URL).

4.
Procedures: Describe each of the procedures, activities, and/or processes used in the intervention, including any enabling or support activities.

5.
For each category of intervention provider (e.g. psychologist, nursing assistant), describe their expertise, background and any specific training given.

6.
Describe the modes of delivery (e.g. face-to-face or by some other mechanism, such as internet or telephone) of the intervention and whether it was provided individually or in a group.

11.
Planned: If intervention adherence or fidelity was assessed, describe how and by whom, and if any strategies were used to maintain or improve fidelity, describe them.

ǂ
Actual: If intervention adherence or fidelity was assessed, describe the extent to which the intervention was delivered as planned.
____N/A______ _____________ ** Authors -use N/A if an item is not applicable for the intervention being described. Reviewers -use '?' if information about the element is not reported/not sufficiently reported. † If the information is not provided in the primary paper, give details of where this information is available. This may include locations such as a published protocol or other published papers (provide citation details) or a website (provide the URL). ǂ If completing the TIDieR checklist for a protocol, these items are not relevant to the protocol and cannot be described until the study is complete.
* We strongly recommend using this checklist in conjunction with the TIDieR guide (see BMJ 2014;348:g1687) which contains an explanation and elaboration for each item.
* The focus of TIDieR is on reporting details of the intervention elements (and where relevant, comparison elements) of a study. Other elements and methodological features of studies are covered by other reporting statements and checklists and have not been duplicated as part of the TIDieR checklist. When a randomised trial is being reported, the TIDieR checklist should be used in conjunction with the CONSORT statement (see www.consort-statement.org) as an extension of Item 5 of the CONSORT 2010 Statement. When a clinical trial protocol is being reported, the TIDieR checklist should be used in conjunction with the SPIRIT statement as an extension of Item 11 of the SPIRIT 2013 Statement (see www.spirit-statement.org). For alternate study designs, TIDieR can be used in conjunction with the appropriate checklist for that study design (see www.equator-network.org). Role of study sponsor and funders, if any, in study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication, including whether they will have ultimate authority over any of these activities ____18___ 5d Composition, roles, and responsibilities of the coordinating centre, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable (see Item 21a for data monitoring committee) ______n/a____ Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) __20____

Methods: Assignment of interventions (for controlled trials)
Allocation: Sequence generation 16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions ____12_______ Allocation concealment mechanism 16b Mechanism of implementing the allocation sequence (eg, central telephone; sequentially numbered, opaque, sealed envelopes), describing any steps to conceal the sequence until interventions are assigned _____11-12_____ Implementation 16c Who will generate the allocation sequence, who will enrol participants, and who will assign participants to interventions ____8_______ Blinding (masking) 17a Who will be blinded after assignment to interventions (eg, trial participants, care providers, outcome assessors, data analysts), and how ____12_______ 17b If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant's allocated intervention during the trial _____n/a_____

Methods: Data collection, management, and analysis
Data collection methods 18a Plans for assessment and collection of outcome, baseline, and other trial data, including any related processes to promote data quality (eg, duplicate measurements, training of assessors) and a description of study instruments (eg, questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be found, if not in the protocol __13-14 ; table 3__ 18b Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols _____13________ Definition of analysis population relating to protocol non-adherence (eg, as randomised analysis), and any statistical methods to handle missing data (eg, multiple imputation) _____15-16_____

Methods: Monitoring
Data monitoring 21a Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and competing interests; and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed _____16_____ 21b Description of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial ___n/a_____

Harms 22
Plans for collecting, assessing, reporting, and managing solicited and spontaneously reported adverse events and other unintended effects of trial interventions or trial conduct _____15____ Auditing 23 Frequency and procedures for auditing trial conduct, if any, and whether the process will be independent from investigators and the sponsor _____17______ How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial _____16_____

Declaration of interests 28
Financial and other competing interests for principal investigators for the overall trial and each study site ______19_______ Access to data 29 Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that limit such access for investigators